Electrical Grounding and Sleep Quality in Hospitalised Patients With Cancer

Design. Prospective, randomised, sham-controlled, participant-blinded, parallel two-group trial conducted in the oncology ward of New Taipei Municipal TuCheng Hospital.

Allocation. Participants were allocated to true grounding or sham grounding by a randomised block design generated with the Research Randomizer web service. The true and sham cords were externally indistinguishable, differing only in whether a conductive connection was completed internally; participants were therefore blinded to allocation. Investigators who applied the intervention and measured body voltage were necessarily aware of allocation.

Intervention. Grounding was delivered through a medical-grade hydrogel patch of approximately 4 x 5 cm applied to the forehead and connected by a grounding cord, with the impedance of the completed circuit limited to less than 100 ohms. In hospital the cord was connected to the earth terminal of the bedside mains outlet; at home it was connected to a metal window frame, because domestic outlets in Taiwan do not reliably provide a standard earth terminal. Grounding was applied from 21:00 to 06:00 on two consecutive nights in the ward, suspended until discharge, and then applied nightly at home for at least six hours until the outpatient follow-up visit.

Body voltage. The alternating potential at the fingertip was measured with a digital multimeter while the participant lay in bed, both before and during grounding, on each in-hospital study night and once at home.

Remote bedroom assessment. Within two days of discharge a researcher conducted a video call to record the electromagnetic environment of the bedroom using a purpose-designed questionnaire, and to teach the participant to measure body voltage and to ground safely at home.

Statistical analysis. The primary between-group treatment effect was estimated by analysis of covariance, regressing each follow-up score on allocation arm with the corresponding baseline score as covariate. Every model was repeated on rank-transformed data as a sensitivity analysis. All tests were two-sided at the 5% level.

Inclusion criteria

• Inpatients of the oncology ward aged 20 to 79 years
• Subjective complaint of insomnia, with a Pittsburgh Sleep Quality Index global score of 10 or greater at baseline
• Histologically or clinically confirmed cancer of any stage from 0 to IV
• Intact forehead skin permitting application of a grounding patch
• Scheduled hospital admission of more than three days
• Able and willing to give written informed consent

Exclusion criteria

• Baseline Pittsburgh Sleep Quality Index global score of 9 or less
• Known or suspected pregnancy
• History of alcohol dependence with less than two months of abstinence
• Recent use of an indoor grounding product during sleep for more than one month
• Habitually walking barefoot outdoors for more than one hour a day for more than one month
• Unable or unwilling to complete the study procedures